drugset / Trial / NCT00430248
Efficacy and Safety of Oral Febuxostat in Participants With Gout
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to compare the efficacy and safety of febuxostat, once Daily (QD), to allopurinol in subjects with hyperuricemia and gout.
Timeline
- Start
- 2007-02
- Primary completion
- 2008-03
- Completion
- 2008-03
Publications
- Results Becker MA, Schumacher HR, Espinoza LR, Wells AF, MacDonald P, Lloyd E, Lademacher C. The urate-lowering efficacy and safety of febuxostat in the treatment of the hyperuricemia of gout: the CONFIRMS trial. Arthritis Res Ther. 2010;12(2):R63. doi: 10.1186/ar2978. Epub 2010 Apr 6.
- Results Wortmann RL, Macdonald PA, Hunt B, Jackson RL. Effect of prophylaxis on gout flares after the initiation of urate-lowering therapy: analysis of data from three phase III trials. Clin Ther. 2010 Dec;32(14):2386-97. doi: 10.1016/j.clinthera.2011.01.008.
- Results Becker MA, MacDonald PA, Hunt B, Gunawardhana L. Treating hyperuricemia of gout: safety and efficacy of febuxostat and allopurinol in older versus younger subjects. Nucleosides Nucleotides Nucleic Acids. 2011 Dec;30(12):1011-7. doi: 10.1080/15257770.2011.603715.
- Results Chohan S, Becker MA, MacDonald PA, Chefo S, Jackson RL. Women with gout: efficacy and safety of urate-lowering with febuxostat and allopurinol. Arthritis Care Res (Hoboken). 2012 Feb;64(2):256-61. doi: 10.1002/acr.20680.
- Becker MA, MacDonald PA, Hunt BJ, Jackson RL. Diabetes and gout: efficacy and safety of febuxostat and allopurinol. Diabetes Obes Metab. 2013 Nov;15(11):1049-55. doi: 10.1111/dom.12135. Epub 2013 Jun 12.
- Jackson RL, Hunt B, MacDonald PA. The efficacy and safety of febuxostat for urate lowering in gout patients >/=65 years of age. BMC Geriatr. 2012 Mar 21;12:11. doi: 10.1186/1471-2318-12-11.
- Wells AF, MacDonald PA, Chefo S, Jackson RL. African American patients with gout: efficacy and safety of febuxostat vs allopurinol. BMC Musculoskelet Disord. 2012 Feb 9;13:15. doi: 10.1186/1471-2474-13-15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Allopurinol | Small molecule | 200 mg | Oral |
| Comparator | Allopurinol | Small molecule | 300 mg | Oral |
| Subject | Febuxostat | Small molecule | 40 mg | Oral |
| Subject | Febuxostat | Small molecule | 80 mg | Oral |